Positive phase III results for rituximab biosimilar ABP 798

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Positive phase III results for rituximab biosimilar ABP 798

Biosimilares/Investigación | Posted 01/03/2019 0 Post your comment

Biotech giant Amgen, and its partner Allergan, announced on 24 January 2019 positive data from a phase I/III study of its rituximab biosimilar (ABP 798) compared to Rituxan (rituximab).

Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.

The randomized, double-blind, study (NCT02792699) evaluated the pharmacokinetics (PKs) and pharmacodynamics (PDs), efficacy and safety of ABP 798 compared to the originator biological, Roche’s MabThera/Rituxan (rituximab), in patients with moderate-to-severe rheumatoid arthritis. A total of 311 patients were enrolled and randomized (1:1:1) to receive either ABP 798 (n = 104), US-sourced rituximab (n = 103) or EU-sourced rituximab (n = 104), administered as an intravenous (IV) infusion at baseline and again at Week 24. It was carried out at 55 centres in Bulgaria, Estonia, Germany, Hungary, Poland and the US. The trial was completed in October 2018.

The results met the primary objective of the study, which was PK similarity of ABP 798 compared to MabThera/Rituxan. The PK endpoints of the study were area under the serum concentration–time curve (AUC) and maximum serum concentration (Cmax), both of which were within the pre-specified equivalence margin. The pre-specified equivalence in efficacy endpoint was measured by Disease Activity Score 28-joint count C reactive protein (DAS28-CRP) change from baseline at Week 24. Overall, safety and immunogenicity of ABP 798 were also reported to be comparable to MabThera/Rituxan.

The results, according to Amgen, ‘show pharmacokinetic and clinical equivalence between ABP 798 and rituximab, further demonstrating Amgen’s commitment to providing patients with access to high quality, biological therapies’.

The company says that this is the first of two studies intended to form the basis for global regulatory submissions for ABP 798. The second study is being conducted in patients with non-Hodgkin’s lymphoma.

Amgen has 10 biosimilars in its portfolio. These include two that are approved in the US, Amjevita (adalimumab-atto) and Mvasi (bevacizumab-awwb) [1], and three that are approved in the European Union (EU), Amgevita (adalimumab), Mvasi (bevacizumab) and Solymbic (adalimumab) [2].

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 1]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 1]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Amgen, Clinicaltrials.gov